check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100493

ClinicalTrials.gov Identifier:

NCT00682019

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study Evaluation the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction for 10 weeks

Trial purpose

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
    - History of unresponsiveness to sildenafil
    - Stable sexual relationship for > 6 month.
  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy.

Trial summary

Enrollment Goal
383
Trial Dates
December 2003 - August 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

  • Per-patient success rates based on Sexual Encounter Profile, Question 3
    date_rangeTime Frame:
    10 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Per-subject success rates based on Sexual Encounter Profile, Question 2
    date_rangeTime Frame:
    10 weeks
    enhanced_encryption
    Safety Issue:
    no
  • International Index of Erectile Function- Erectile Function domain score
    date_rangeTime Frame:
    10 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question (GAQ)
    date_rangeTime Frame:
    10 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    10 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects with Erectile Dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.